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Safety of medical interventions in children versus adults

Dimitrios Lathyris1, Orestis A Panagiotou, Maria Baltogianni

  • 1Intensive Care Unit, General Hospital G. Gennimatas, Thessaloniki, Greece;

Pediatrics
|February 26, 2014
PubMed

Insights

The risk of harm from medications may differ between children and adults, with significant discrepancies noted in some cases. Extrapolating adult trial data to pediatric populations requires caution due to potential differences in drug safety profiles.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Clinical Trials

Background:

  • Assessing drug safety in pediatric populations is crucial.
  • Randomized controlled trials (RCTs) are a primary source of evidence for drug safety.
  • Differences in drug response between pediatric and adult populations are known to exist.

Purpose of the Study:

  • To compare the risk of harm from pharmacologic interventions in pediatric versus adult randomized controlled trials (RCTs).
  • To evaluate the reliability of extrapolating adult drug safety data to children.

Main Methods:

  • Systematic reviews from the Cochrane Database of Systematic Reviews were analyzed.
  • Seven categories of harms/harm-related endpoints were assessed: severe harms, withdrawals due to harms, any harm, organ system-level harms, specific harms, withdrawals for any reason, and mortality.
  • Relative Odds Ratios (ROR) and summary ROR (sROR) were calculated to compare harm risks between adult and pediatric RCTs.

Main Results:

  • 176 meta-analyses from 669 adult and 184 pediatric RCTs were identified.
  • Statistically significant discrepancies between adults and children were found only for headache (sROR 0.82).
  • Nominally significant discrepancies were identified in 12 of 165 meta-analyses, with twofold or greater differences suggested in 36% of analyses.

Conclusions:

  • Evidence on drug-related harms in pediatric populations has significant uncertainty.
  • Extrapolation of evidence from adult to pediatric RCTs may be unreliable.
  • Clinically important discrepancies in drug-induced harms between children and adults were identified.
Abstract

Keywords:
adultschildrencomparative safetyharmsmortalitypharmacologic interventionswithdrawals

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